In this week's edition...
— A Step Backward — No Voice for Stakeholders in Updated Reconciliation Provisions. Click here to read the blog.
— Scaling the Patient Perspective in Health Technology Assessments. Click here to read the article.
— Disability and Patient Advocacy Groups Raise Concerns Over CHCF's Decision to Fund ICER. Click here to read the letter.
— DOJ and HHS Issue New Guidance on Nondiscrimination in Telehealth. Click here to view the press release.
— New ISPOR Report Published, Call for Comments, Upcoming Events, and More! See details below.
— PCORI Engagement Award Program Offers New Funding to Build Capacity for Small Organizations to Engage in PCOR/CER. Click here to view the blog.
— PIPC Submits Comments on ICER's Assessment of ALS Treatments. Click here to read the letter.
— HHS Report Highlights Progress on PCOR Data Infrastructure. Click here to read the article.
— Emerging Threats in States for Use of Discriminatory Metrics. See details below.
— What Happens in Countries Using QALYs and Cost-Based Thresholds? See details below.
— ICER's QALY-Based Study Topics. See details below.
— Upcoming Events and Webinars. See details below.
— AHRQ Effective Program Updates. See details below.
— A Step Backward — No Voice for Stakeholders in Updated Reconciliation Provisions. Click here to read the blog.
— Scaling the Patient Perspective in Health Technology Assessments. Click here to read the article.
— Disability and Patient Advocacy Groups Raise Concerns Over CHCF's Decision to Fund ICER. Click here to read the letter.
— DOJ and HHS Issue New Guidance on Nondiscrimination in Telehealth. Click here to view the press release.
— New ISPOR Report Published, Call for Comments, Upcoming Events, and More! See details below.
— PCORI Engagement Award Program Offers New Funding to Build Capacity for Small Organizations to Engage in PCOR/CER. Click here to view the blog.
— PIPC Submits Comments on ICER's Assessment of ALS Treatments. Click here to read the letter.
— HHS Report Highlights Progress on PCOR Data Infrastructure. Click here to read the article.
— Emerging Threats in States for Use of Discriminatory Metrics. See details below.
— What Happens in Countries Using QALYs and Cost-Based Thresholds? See details below.
— ICER's QALY-Based Study Topics. See details below.
— Upcoming Events and Webinars. See details below.
— AHRQ Effective Program Updates. See details below.
What We're Reading
1. Chairman's Corner: A Step Backward — No Voice for Stakeholders in Updated Reconciliation Provisions. The recent draft reconciliation legislation creating new health care payment policies did not include the provisions recommended by the National Council on Disability extending the Affordable Care Act’s ban on use of QALYs in Medicare across federal programs or an unambiguous QALY ban. The legislation also omitted an earlier provision to allow affected stakeholders to provide input in the negotiation provisions outlined in Section 1194.
In response, PIPC Chair Tony Coelho published a new blog that criticizes the updated reconciliation package's provisions for being unresponsive to "calls from the disability community to unambiguously bar the use of discriminatory value metrics like the quality-adjusted life year (QALY) across federal programs." Additionally, he raised that the new provisions also fail to provide opportunities for affected stakeholders to provide input. He added, that the National Council on Disability urged Congress not to rely on QALYs and later strongly encouraged the “inclusion of an unambiguous ban on the QALY within the text of the Build Back Better Act (H.R. 5367) in such a way as to convey unequivocal application to the drug price negotiation process” and further recommended extending the QALY ban in Medicare across federal programs as part of their Health Equity Framework." Click here to read the full blog piece. Click here to view the new legislative text. Click here to view the NCD letter to Congress. Click here to view the NCD Health Equity Framework, recommendation #8.
2. Scaling the Patient Perspective in Health Technology Assessments. As detailed in an article in Health Affairs, payers have begun to adopt formalized health technology assessments (HTAs) "in an effort to allocate health care resources most efficiently to the highest value health interventions." The authors note that an HTA "estimates the value of health interventions by estimating their net clinical and economic benefits." The problem with taking the HTA approach is that "current standards for the conduct of HTAs may not accurately represent the value to patients of specific interventions because such standards do not measure benefits and costs from the patient perspective. A core pillar of patient-centered research and care is the appropriate selection and use of patient input—for example, around which clinical and economic outcomes to elevate—in designing studies that generate outcomes that matter to patients. Many research teams and disciplines have begun to adopt patient-important outcomes and to account for patient perspectives in decisions about treatment options." Click here to read the article.
3. Disability and Patient Advocacy Groups Raise Concerns Over CHCF's Decision to Fund ICER. On July 19th, PIPC joined the Cystic Fibrosis Research Institute (CFRI), Disability Rights California, DREDF, the Coelho Center, and Familia Unida, among others, on a letter to the California Health Care Foundation (CHCF) to (1) applaud the Foundation on its focus on fair access to health care and (2) raise concerns about the equity implications of the Foundation's recent announcement to fund ICER. The letter explains that ICER uses "discriminatory and flawed comparative effectiveness metrics such as the QALY to assess the value of medicines." The undersigned organizations are urging the Foundation to "ensure that ICER does not use discriminatory, biased value assessments or comparative effectiveness measures as they complete CHCF-funded work" and "to assure Californians that the work it is funding will not be used against patients and people with disabilities to drive health policy." Click here to view the letter.
Additionally, PIPC Chair Tony Coelho published a blog, on June 21, that outlines concerns about the use of ICER's discriminatory value assessment metrics in California. He noted that, as part of CHCF's funding announcement, ICER recognized proudly that policymakers are now “regularly referencing ICER’s health-benefit price benchmarks” and made no reference to the potential for discrimination from use of an inherently discriminatory metric to drive health care decisions. He also urged policymakers in California to not ignore the recommendations of the many disability and patient advocacy groups on this issue. Click here to view the blog.
4. DOJ and HHS Issue New Guidance on Nondiscrimination in Telehealth. On Friday, July 29, the Department of Justice (DOJ) and the Department of Health and Human Services (HHS) issued joint guidance on nondiscrimination in telehealth. This guidance aims to provide clarity on how federal nondiscrimination laws require accessibility for people with disabilities and others in health care provided via telehealth. Nondiscrimination laws, including Sec. 504 of the Rehabilitation Act of 1973, Title VI of the Civil Rights Act of 1964 and Section 1557 of the Patient Protection and Affordable Care Act, require that telehealth be accessible to people with disabilities and limited English proficient persons. They work together to eradicate discrimination and protect access to health care access for all, especially those with disabilities. Assistant Attorney General Kristen Clarke of the Justice Department's Civil Rights Division stated, "the DOG will vigorously enforce the ADA and other civil rights laws to ensure that health care providers offering telehealth services are doing so free from discrimination." Click here to view the press release.
5. New ISPOR Report Published, Call for Comments, Upcoming Events, and More! ISPOR is preparing to respond to call for comments on a draft guidance document by the U.S. Food and Drug Administration: “Patient-Focused Drug Development: Selecting, Developing, or Modifying Fit-for-Purpose Clinical Outcome Assessments.” We ask that members who would like to provide input please do so by August 18th using the following link: Submit Comments. The ISPOR Machine Learning Methods in HEOR Task Force published a new ISPOR Report, titled “Machine Learning Methods in Health Economics and Outcomes Research—the PALISADE Checklist: an ISPOR Task Force Good Practices Report,” in the July 2022 issue of Value in Health. Click here to access the article and view the press release here.
6. PCORI Engagement Award Program Offers New Funding to Build Capacity for Small Organizations to Engage in PCOR/CER. The October 2022 Cycle of the Eugene Washington PCORI Engagement Award Program is now open. This funding cycle has a new funding opportunity for small groups: Building Capacity for Small Organizations to Engage in Patient-Centered Outcomes Research (PCOR)/Comparative clinical Effectiveness Research (CER). This cycle also offers funding for three other Engagement Award (EA) opportunities: Capacity Building, Dissemination Initiative, and Stakeholder Convening Support. Learn about all four funding opportunities below. Since 2014, the EA Program has awarded over $140 million to more than 680 projects. All of these projects help build communities ready to take part in PCOR, which is a type of CER. Click here to view the blog.
7. PIPC Submits Comments on ICER's Assessment of ALS Treatments. In a letter to the Institute for Clinical and Economic Review (ICER), the Partnership to Improve Patient Care (PIPC) submitted feedback on ICER's assessment of treatments for amyotrophic lateral sclerosis (ALS). The letter is critical of ICER's model structure for failing to appropriately represent a progressive disease such as ALS. PIPC also encourages ICER to factor in caregiver burden, as well as abandon the use of the discriminatory quality-adjusted life years (QALY) metric. "Given the severity of the disease, it is imperative that patients are able to access treatments as they become available," wrote PIPC Chair Tony Coelho. "PIPC encourages ICER to revisit its modeling choices to ensure that the model accurately represents the needs of and treatment value to the ALS patient population." Click here to also view the comments submitted by the ALS Association.
8. HHS Report Highlights Progress on PCOR Data Infrastructure. An article in Healthcare Innovation discusses a recent report of the U.S Department of Health & Human Services Office of the Assistant Secretary for Planning and Evaluation (ASPE) that "highlights progress on the collection, linkage, and analysis of data for patient-centered outcomes research. The ASPE annual report highlights the accomplishments of 34 multi-agency projects to build data capacity and support the HHS mission to advance science and improve knowledge about the comparative effectiveness of health care interventions. In fiscal year 2021, the report focuses on projects aligned with four national health priorities—COVID-19, maternal health, health equity and social determinants of health (SDOH), and the opioid crisis. The section on social determinants and health equity gives a flavor of the type of projects being supported." Click here to read the article.
Emerging Threats in States for Use of Discriminatory Metrics
Several states are considering policies that would reference entities such as the Institute for Clinical and Economic Review (ICER), which calls the discriminatory quality-adjusted life year (QALY) the “gold standard” for value assessment, and others are considering policies to import QALY-based coverage and reimbursement decisions from other countries that restrict access to care. We encourage you to keep track of all state-based threats using this new website tracking state activities. Key issues are highlighted below.
California
ICER has received a grant from the California Health Care Foundation to develop annual unsupported price increase reports as well as a policymaker guide for using its research to determine “fair” access and pricing to drugs. Advocates are concerned of the implications of this grant given ICER’s reliance on QALYs. Simultaneously, the California legislature is considering AB 1130, which would establish the Office of Health Care Affordability to develop policies for lowering health care costs for consumers, set and enforce cost targets, and create a state strategy for controlling the cost of health care. This bill does not currently contain a ban on the use of the QALY. Click here to view the letter to CHCF from advocates.
New York
On April 27, 2022, SB 8901 was introduced in the New York Senate, which would import QALYs from Canada by directly referencing the QALY-based prices paid for prescription drugs in four Canadian provinces. It has passed out of the Finance Committee and been referred to the Rules Committee. Click here to view the bill. Click here to learn more about state efforts to import discriminatory QALYs from Canada.
Oregon
Oregon's waiver application, submitted to CMS on February 18, 2022 defended the state’s use of QALYs and continues to request authority to conduct reviews of drugs approved through FDA’s accelerated pathway to allow for restricted coverage. Disability and patient stakeholders have submitted comments to CMS asking that it reject Oregon’s use of the discriminatory QALY. Click here to read comments submitted by PIPC along with 62 other groups. Click here to view letters from Disability Rights Oregon and Paul Terdal. Click here to view the letter from Patients Rights Action Fund.
Massachusetts
The Massachusetts House and Senate have each taken the positive step of introducing An Act Advancing Health Care Research and Decision-Making Centered on Patients and People with Disabilities, H.201 and S.753. This bill would enshrine essential patient protections including a ban on the use of the QALY, a requirement for research to meet patient-centeredness criteria, and robust engagement of the patient and disability communities in health care decision making. Governor Charlie Baker filed his health care bill, SB 2774, An Act Investing in the Future of our Health, on March 17, 2022. The bill expands the Health Policy Commission’s authority to determine the value of a drug beyond Medicaid to private payers. As written, the bill allows for use of cost-effectiveness assessments and analysis by a third-party, and it does not include a QALY ban. The bill requires disclosure of methods used by third parties and disclosures of potential limitations of that research. In a hearing on SB 2774 on April 11, patient advocates testified that the bill as written has the potential to discriminate and must include a QALY ban.
International News: What Happens in Countries Using QALYs and Cost-Based Thresholds?
Other countries are often referenced as examples of how the use of QALYs or similar cost-based thresholds impact access to care.
ICER's QALY-Based Study Topics
The Institute for Clinical Economic Review (ICER) conducts cost effectiveness studies for insurers using the cost-per-QALY methodology. ICER provides guidance on its website for patients and patient advocates to provide direct input related to their experiences with the disease. Click here to provide patient input. Click here to view the topics and deadlines.
Upcoming Events and Webinars
Engagement Awards October 2022 Cycle -- Applicant Office Hours
August 4, 2022
Click here for details.
Medical Journal Articles
Challenges and Opportunities for Advancing Patient-Centered Clinical Decision Support: Findings from a Horizontal Scan, click here to view.
Can Alternative Payment Models and Value-Based Insurance Design Alter the Course of Diabetes in the United States? Click here to view.
A Pragmatic Guide to Assessing Real Option Value for Medical Technologies, click here to view.
Stakeholder Engagement Infrastructure to Support Multicenter Research Networks: Advances from the Clinical Research Networks Participating in PCORnet, click here to view.
Use of Pragmatic and Explanatory Trial Designs in Acute Care Research: Lessons from COVID-19, click here to view.
Impact of the COVID-19 Pandemic on Healthcare Resource Utilization Across Selected Disease Areas in the USA, click here to view.
Total Cost of Care Differences in National Comprehensive Cancer Center (NCCN) Concordant and Non-Concordant Breast Cancer Patients, click here to view.
The Role Of Prices In Excess US Health Spending, click here to view.
Application of Quantitative Bias Analysis for Unmeasured Confounding in Cost–Effectiveness Modelling, click here to view.
Seriously Ill Individuals—A Canary in the Coal Mine for Medicare’s Transition to Accountable Health Care, click here to view.
Perceptions and Use of Telehealth Among Mental Health, Primary, and Specialty Care Clinicians During the COVID-19 Pandemic, click here to view.
Effect of Electronic Symptom Monitoring on Patient-Reported Outcomes Among Patients With Metastatic Cancer: A Randomized Clinical Trial, click here to view.
AHRQ Effective Program Updates
1. Chairman's Corner: A Step Backward — No Voice for Stakeholders in Updated Reconciliation Provisions. The recent draft reconciliation legislation creating new health care payment policies did not include the provisions recommended by the National Council on Disability extending the Affordable Care Act’s ban on use of QALYs in Medicare across federal programs or an unambiguous QALY ban. The legislation also omitted an earlier provision to allow affected stakeholders to provide input in the negotiation provisions outlined in Section 1194.
In response, PIPC Chair Tony Coelho published a new blog that criticizes the updated reconciliation package's provisions for being unresponsive to "calls from the disability community to unambiguously bar the use of discriminatory value metrics like the quality-adjusted life year (QALY) across federal programs." Additionally, he raised that the new provisions also fail to provide opportunities for affected stakeholders to provide input. He added, that the National Council on Disability urged Congress not to rely on QALYs and later strongly encouraged the “inclusion of an unambiguous ban on the QALY within the text of the Build Back Better Act (H.R. 5367) in such a way as to convey unequivocal application to the drug price negotiation process” and further recommended extending the QALY ban in Medicare across federal programs as part of their Health Equity Framework." Click here to read the full blog piece. Click here to view the new legislative text. Click here to view the NCD letter to Congress. Click here to view the NCD Health Equity Framework, recommendation #8.
2. Scaling the Patient Perspective in Health Technology Assessments. As detailed in an article in Health Affairs, payers have begun to adopt formalized health technology assessments (HTAs) "in an effort to allocate health care resources most efficiently to the highest value health interventions." The authors note that an HTA "estimates the value of health interventions by estimating their net clinical and economic benefits." The problem with taking the HTA approach is that "current standards for the conduct of HTAs may not accurately represent the value to patients of specific interventions because such standards do not measure benefits and costs from the patient perspective. A core pillar of patient-centered research and care is the appropriate selection and use of patient input—for example, around which clinical and economic outcomes to elevate—in designing studies that generate outcomes that matter to patients. Many research teams and disciplines have begun to adopt patient-important outcomes and to account for patient perspectives in decisions about treatment options." Click here to read the article.
3. Disability and Patient Advocacy Groups Raise Concerns Over CHCF's Decision to Fund ICER. On July 19th, PIPC joined the Cystic Fibrosis Research Institute (CFRI), Disability Rights California, DREDF, the Coelho Center, and Familia Unida, among others, on a letter to the California Health Care Foundation (CHCF) to (1) applaud the Foundation on its focus on fair access to health care and (2) raise concerns about the equity implications of the Foundation's recent announcement to fund ICER. The letter explains that ICER uses "discriminatory and flawed comparative effectiveness metrics such as the QALY to assess the value of medicines." The undersigned organizations are urging the Foundation to "ensure that ICER does not use discriminatory, biased value assessments or comparative effectiveness measures as they complete CHCF-funded work" and "to assure Californians that the work it is funding will not be used against patients and people with disabilities to drive health policy." Click here to view the letter.
Additionally, PIPC Chair Tony Coelho published a blog, on June 21, that outlines concerns about the use of ICER's discriminatory value assessment metrics in California. He noted that, as part of CHCF's funding announcement, ICER recognized proudly that policymakers are now “regularly referencing ICER’s health-benefit price benchmarks” and made no reference to the potential for discrimination from use of an inherently discriminatory metric to drive health care decisions. He also urged policymakers in California to not ignore the recommendations of the many disability and patient advocacy groups on this issue. Click here to view the blog.
4. DOJ and HHS Issue New Guidance on Nondiscrimination in Telehealth. On Friday, July 29, the Department of Justice (DOJ) and the Department of Health and Human Services (HHS) issued joint guidance on nondiscrimination in telehealth. This guidance aims to provide clarity on how federal nondiscrimination laws require accessibility for people with disabilities and others in health care provided via telehealth. Nondiscrimination laws, including Sec. 504 of the Rehabilitation Act of 1973, Title VI of the Civil Rights Act of 1964 and Section 1557 of the Patient Protection and Affordable Care Act, require that telehealth be accessible to people with disabilities and limited English proficient persons. They work together to eradicate discrimination and protect access to health care access for all, especially those with disabilities. Assistant Attorney General Kristen Clarke of the Justice Department's Civil Rights Division stated, "the DOG will vigorously enforce the ADA and other civil rights laws to ensure that health care providers offering telehealth services are doing so free from discrimination." Click here to view the press release.
5. New ISPOR Report Published, Call for Comments, Upcoming Events, and More! ISPOR is preparing to respond to call for comments on a draft guidance document by the U.S. Food and Drug Administration: “Patient-Focused Drug Development: Selecting, Developing, or Modifying Fit-for-Purpose Clinical Outcome Assessments.” We ask that members who would like to provide input please do so by August 18th using the following link: Submit Comments. The ISPOR Machine Learning Methods in HEOR Task Force published a new ISPOR Report, titled “Machine Learning Methods in Health Economics and Outcomes Research—the PALISADE Checklist: an ISPOR Task Force Good Practices Report,” in the July 2022 issue of Value in Health. Click here to access the article and view the press release here.
6. PCORI Engagement Award Program Offers New Funding to Build Capacity for Small Organizations to Engage in PCOR/CER. The October 2022 Cycle of the Eugene Washington PCORI Engagement Award Program is now open. This funding cycle has a new funding opportunity for small groups: Building Capacity for Small Organizations to Engage in Patient-Centered Outcomes Research (PCOR)/Comparative clinical Effectiveness Research (CER). This cycle also offers funding for three other Engagement Award (EA) opportunities: Capacity Building, Dissemination Initiative, and Stakeholder Convening Support. Learn about all four funding opportunities below. Since 2014, the EA Program has awarded over $140 million to more than 680 projects. All of these projects help build communities ready to take part in PCOR, which is a type of CER. Click here to view the blog.
7. PIPC Submits Comments on ICER's Assessment of ALS Treatments. In a letter to the Institute for Clinical and Economic Review (ICER), the Partnership to Improve Patient Care (PIPC) submitted feedback on ICER's assessment of treatments for amyotrophic lateral sclerosis (ALS). The letter is critical of ICER's model structure for failing to appropriately represent a progressive disease such as ALS. PIPC also encourages ICER to factor in caregiver burden, as well as abandon the use of the discriminatory quality-adjusted life years (QALY) metric. "Given the severity of the disease, it is imperative that patients are able to access treatments as they become available," wrote PIPC Chair Tony Coelho. "PIPC encourages ICER to revisit its modeling choices to ensure that the model accurately represents the needs of and treatment value to the ALS patient population." Click here to also view the comments submitted by the ALS Association.
8. HHS Report Highlights Progress on PCOR Data Infrastructure. An article in Healthcare Innovation discusses a recent report of the U.S Department of Health & Human Services Office of the Assistant Secretary for Planning and Evaluation (ASPE) that "highlights progress on the collection, linkage, and analysis of data for patient-centered outcomes research. The ASPE annual report highlights the accomplishments of 34 multi-agency projects to build data capacity and support the HHS mission to advance science and improve knowledge about the comparative effectiveness of health care interventions. In fiscal year 2021, the report focuses on projects aligned with four national health priorities—COVID-19, maternal health, health equity and social determinants of health (SDOH), and the opioid crisis. The section on social determinants and health equity gives a flavor of the type of projects being supported." Click here to read the article.
Emerging Threats in States for Use of Discriminatory Metrics
Several states are considering policies that would reference entities such as the Institute for Clinical and Economic Review (ICER), which calls the discriminatory quality-adjusted life year (QALY) the “gold standard” for value assessment, and others are considering policies to import QALY-based coverage and reimbursement decisions from other countries that restrict access to care. We encourage you to keep track of all state-based threats using this new website tracking state activities. Key issues are highlighted below.
- Click here to learn more about the potential for Prescription Drug Affordability Boards to discriminate by incorporating the use of QALYS.
- Click here to view the Value Our Health state template legislation that would protect people with disabilities and chronic conditions from the use of QALYs and similar metrics developed by third parties such as ICER in decisions related to reimbursement and coverage, as well as ensure their engagement in decision-making.
- Click here to view a one pager about the flaws in ICER’s methodology.
- Click here to view information from experts on the downside of referencing foreign countries.
- Click here to learn about statutory protections against use of QALYs.
California
ICER has received a grant from the California Health Care Foundation to develop annual unsupported price increase reports as well as a policymaker guide for using its research to determine “fair” access and pricing to drugs. Advocates are concerned of the implications of this grant given ICER’s reliance on QALYs. Simultaneously, the California legislature is considering AB 1130, which would establish the Office of Health Care Affordability to develop policies for lowering health care costs for consumers, set and enforce cost targets, and create a state strategy for controlling the cost of health care. This bill does not currently contain a ban on the use of the QALY. Click here to view the letter to CHCF from advocates.
New York
On April 27, 2022, SB 8901 was introduced in the New York Senate, which would import QALYs from Canada by directly referencing the QALY-based prices paid for prescription drugs in four Canadian provinces. It has passed out of the Finance Committee and been referred to the Rules Committee. Click here to view the bill. Click here to learn more about state efforts to import discriminatory QALYs from Canada.
Oregon
Oregon's waiver application, submitted to CMS on February 18, 2022 defended the state’s use of QALYs and continues to request authority to conduct reviews of drugs approved through FDA’s accelerated pathway to allow for restricted coverage. Disability and patient stakeholders have submitted comments to CMS asking that it reject Oregon’s use of the discriminatory QALY. Click here to read comments submitted by PIPC along with 62 other groups. Click here to view letters from Disability Rights Oregon and Paul Terdal. Click here to view the letter from Patients Rights Action Fund.
Massachusetts
The Massachusetts House and Senate have each taken the positive step of introducing An Act Advancing Health Care Research and Decision-Making Centered on Patients and People with Disabilities, H.201 and S.753. This bill would enshrine essential patient protections including a ban on the use of the QALY, a requirement for research to meet patient-centeredness criteria, and robust engagement of the patient and disability communities in health care decision making. Governor Charlie Baker filed his health care bill, SB 2774, An Act Investing in the Future of our Health, on March 17, 2022. The bill expands the Health Policy Commission’s authority to determine the value of a drug beyond Medicaid to private payers. As written, the bill allows for use of cost-effectiveness assessments and analysis by a third-party, and it does not include a QALY ban. The bill requires disclosure of methods used by third parties and disclosures of potential limitations of that research. In a hearing on SB 2774 on April 11, patient advocates testified that the bill as written has the potential to discriminate and must include a QALY ban.
International News: What Happens in Countries Using QALYs and Cost-Based Thresholds?
Other countries are often referenced as examples of how the use of QALYs or similar cost-based thresholds impact access to care.
- Canada: CF patients are rejoicing after the government finally lifted restricted access to Trikafta, a life-saving drug, however, the government still restricts access to CF drugs Kalydeco and Orkambi for meeting eligibility criteria.
- United Kingdom: Breast cancer patients are thankful for the NHS' decision to finally give Alpelisib and Trodelvy, life-extending drugs, the green light after it was rejected in April.
ICER's QALY-Based Study Topics
The Institute for Clinical Economic Review (ICER) conducts cost effectiveness studies for insurers using the cost-per-QALY methodology. ICER provides guidance on its website for patients and patient advocates to provide direct input related to their experiences with the disease. Click here to provide patient input. Click here to view the topics and deadlines.
- Amyotrophic Lateral Sclerosis (ALS): Draft Evidence Report available. Public comments closed. 8/4/2022: Evidence Report. Model Analysis Plan available. Research Protocol available. Revised Scoping Document available.
- Menopause: Vasomotor Symptoms: Research Protocol available. Revised Scoping Document available. Draft Scoping Document available. Public comments closed. 8/23/2022: Model Analysis Plan.
- Alzheimer's Disease: 10/5/2022: Model Analysis Plan. Research Protocol available. Revised Scoping Document available.
- Beta Thalassemia: Final Evidence Report and Meeting Summary available. Evidence Presentation available. Draft Evidence Report available. Public comments closed. Model Analysis Plan available. Research Protocol available. Revised Scoping Document available.
- COVID-19: Final Evidence Report and Meeting Summary available. Evidence Presentation and Report available. Draft Evidence Report Available. Public comments closed. Model Analysis Plan available. Draft Scoping Document and Research Protocol available.
- Obesity Management: Draft Evidence Report available. Public comments open until 8/8/2022. Model Analysis Plan available. Research Protocol available. Revised Scoping Document available. Draft Scoping Document available. 8/31/2022: Evidence Report.
- Multiple Sclerosis: CIS, RRMS, and SPMS: Research Protocol available. 8/17/2022: Model Analysis Plan. Revised Scoping Document available. Draft Scoping Document available. Public comments closed.
- Gene Therapies for Hemophilia A and B: Model Analysis Plan available. 9/13/2022: Draft Evidence Report. Revised Scoping Document available. Draft Scoping Document available. Public comments closed.
- Unsupported Price Increases Occurring in 2020 in California: Protocol available. 10/13/2022: Final Report.
- Type 2 Diabetes: Final Evidence Report and Meeting Summary available. Evidence Presentation available. Evidence Report available. Draft Scoping Document and Research Protocol available.
- Hypertrophic Cardiomyopathy: Final Evidence Report and Meeting Summary available. Evidence Report Available. Evidence Presentation available.
- Asthma: Final Evidence Report and Meeting Summary available. Evidence Presentation available. Evidence Report available.
Upcoming Events and Webinars
Engagement Awards October 2022 Cycle -- Applicant Office Hours
August 4, 2022
Click here for details.
Medical Journal Articles
Challenges and Opportunities for Advancing Patient-Centered Clinical Decision Support: Findings from a Horizontal Scan, click here to view.
Can Alternative Payment Models and Value-Based Insurance Design Alter the Course of Diabetes in the United States? Click here to view.
A Pragmatic Guide to Assessing Real Option Value for Medical Technologies, click here to view.
Stakeholder Engagement Infrastructure to Support Multicenter Research Networks: Advances from the Clinical Research Networks Participating in PCORnet, click here to view.
Use of Pragmatic and Explanatory Trial Designs in Acute Care Research: Lessons from COVID-19, click here to view.
Impact of the COVID-19 Pandemic on Healthcare Resource Utilization Across Selected Disease Areas in the USA, click here to view.
Total Cost of Care Differences in National Comprehensive Cancer Center (NCCN) Concordant and Non-Concordant Breast Cancer Patients, click here to view.
The Role Of Prices In Excess US Health Spending, click here to view.
Application of Quantitative Bias Analysis for Unmeasured Confounding in Cost–Effectiveness Modelling, click here to view.
Seriously Ill Individuals—A Canary in the Coal Mine for Medicare’s Transition to Accountable Health Care, click here to view.
Perceptions and Use of Telehealth Among Mental Health, Primary, and Specialty Care Clinicians During the COVID-19 Pandemic, click here to view.
Effect of Electronic Symptom Monitoring on Patient-Reported Outcomes Among Patients With Metastatic Cancer: A Randomized Clinical Trial, click here to view.
AHRQ Effective Program Updates
- Systematic Review: Schedule of Visits and Televisits for Routine Antenatal Care. Click here to view.
- Systematic Review: Telehealth for Women's Preventive Services. Click here to view.
- Systematic Review: Living Systematic Review on Cannabis and Other Plant-Based Treatments for Chronic Pain. Click here to view.
- Systematic Review: Maternal and Child Outcomes Associated With the Special Supplemental Nutrition Program for Women, Infants, and Children (WIC). Click here to view.
- Research Report: Research Gaps in Women’s Health: 2022. Click here to view.
- Systematic Review: Treatments for Acute Pain. Click here to view.
- Systematic Review: Models of Care That Include Primary Care for Adult Survivors of Childhood Cancer: A Realist Review. Click here to view.
- Integrated and Comprehensive Pain Management Programs: Effectiveness and Harms. Click here to view.
